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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 486

Braskem PP Americas, Inc., and
Braskem Europe

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Ethylene/propylene copolymers (CAS Reg. No. 9010-79-1) polymerized in the presence of propylene homopolymer (CAS Reg. No. 9003-07-0) complying with 21 CFR 177.1520(c) Item 1.1, to produce an inseparable blend of the two polymers.
Notifier: Braskem PP Americas, Inc.
Manufacturer: Braskem PP Americas, Inc., and
Braskem Europe
Intended Use: As the basic polymer used in the production of articles intended to contact food.
Limitations/Specifications*: The finished polymer is intended for use in contact with all types of food under Conditions of Use A through H, as described in Tables 1 and 2, respectively. Polymeric additives permitted for use in olefin polymers complying 21 CFR 177.1520(c), items 1.1(a) and 3.2(a) may also be used in this food-contact substance, subject to the prescribed limitations and specifications.
Effective Date: Apr 15, 2005
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (419 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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